Financial Performance - The company reported a net loss per share of 2.25forthecurrentquarter,comparedtoanetlossof2.10 in the previous quarter[14]. - The net loss for the three months ended September 30, 2024, was 16,425million,comparedtoanetlossof8,079 million in the same period of 2023, indicating a worsening of 103.1%[16]. - For the nine months ended September 30, 2024, the net income was 24,912,000comparedtoanetlossof45,030,000 in the same period of 2023, indicating a significant improvement[20]. - The basic net loss per share for the three months ended September 30, 2024, was (2.25),comparedto(2.10) for the same period in 2023[130]. Revenue and Growth - Revenue for the three months ended September 30, 2024, was 13,120million,anincreasefrom8,079 million in the same period of 2023, representing a year-over-year growth of 62.5%[16]. - The Company recognized revenue of 52.7millionunderthePrevailAgreementduringtheninemonthsendedSeptember30,2024,comparedto23.4 million for the same period in 2023[99]. - Revenue recognized under the TG License Agreement for the nine months ended September 30, 2024, was 8.0million,withnorevenuerecognizedinthethirdquarterof2024[87].−RevenuerecognizedundertheNovartisAgreementforthethreemonthsendedSeptember30,2024,was0.6 million, a decrease from 7.6millionforthesameperiodin2023[95].AssetsandLiabilities−AsofSeptember30,2024,totalassetsdecreasedto153.258 million from 159.781millionasofDecember31,2023[12].−Currentliabilitiessignificantlyreducedto11.982 million from 49.987millionasofDecember31,2023[12].−Totalstockholders′equityincreasedto64.866 million from 18.861millionasofDecember31,2023[13].−Cashandcashequivalentsattheendoftheperiodwere98,752,000, down from 122,231,000attheendofthepreviousyear[20].OperatingExpenses−Researchanddevelopmentexpensesdecreasedto13,084 million for the three months ended September 30, 2024, down from 15,850millioninthesameperiodof2023,areductionof17.521,851 million, compared to 25,483millioninthesameperiodof2023,reflectingadecreaseof14.42.022 million, a decrease from 2.530millionin2023[72].FundingandCapital−Thecompanywillneedsubstantialadditionalfundingtocontinueitsresearchprogramsandproductdevelopmentactivities[11].−TheCompanyraisedapproximately37.0 million in net proceeds from the March 2024 Public Offering of 2,500,000 shares at 16.00pershare[79].−Thecompanyisfocusedonraisingadditionalcapitaltofundongoingresearchanddevelopmentandachieveprofitableoperations[22].CompetitionandMarketConditions−Thecompanyfacessignificantcompetitioninrapidlychangingindustries,whichmayimpactitsfinancialcondition[11].−Theregulatorylandscapefortherapeuticproductcandidatesiscomplexandsubjecttochange,whichcouldresultinunexpectedcosts[11].StockandEquity−ThebalanceofcommonsharesasofSeptember30,2023,was3,882,739,reflectinganincreasefrom3,725,689sharesasofDecember31,2022[18].−TheCompanyhasundergonea1−for−30reversestockspliteffectiveFebruary13,2024,adjustingallhistoricalshareamountsaccordingly[27].−AsofSeptember30,2024,therewere29,935stockoptionsoutstandingunderthe2015StockIncentivePlan,withnoremainingstockoptionsavailabletobegranted[104].CashFlowandFinancingActivities−NetcashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024,was39,762,000, a decrease from 75,691,000inthesameperiodof2023[20].−Thecompanyreportedanetcashprovidedbyfinancingactivitiesof44,530,000 for the nine months ended September 30, 2024, compared to 2,559,000inthesameperiodof2023[20].−TheCompany’s2024TermLoanhasaprincipalamountof22.5 million, used to repay the outstanding balance under the Revolving Line[60]. Future Outlook - The company plans to continue its market expansion and product development strategies to enhance future revenue growth[16]. - The company has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[11]. - The company has a limited operating history, making it difficult to evaluate current business and future prospects[11].